Left Atrial Appendage Exclusion
Conditions
Brief summary
The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
Detailed description
Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ Left Atrial Appendage (LAA) Exclusion Clip at up to 25 sites in the United States. Subjects will be followed at 30 days, 3 months, 12-months and annually for 36-months.
Interventions
DEVICEPenditure™ Left Atrial Appendage (LAA) Exclusion System
Exclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
Sponsors
Medtronic Cardiac Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is indicated to be treated with the Penditure™ left atrial appendage (LAA) Exclusion System * Greater than or equal to 18 years of age * The subject is willing and able to provide written informed consent and comply with study visit requirements
Exclusion criteria
* Prior left atrial appendage (LAA) isolation attempt(s) * Need for emergent cardiac surgery * Subject is contraindicated for multi-detector computed tomography (MDCT) and/or transesophageal echocardiogram (TEE) * Life expectancy of less than 12 months * History of cardiac surgery * Pericarditis * Presence of thrombus in the left atrium or left atrial appendage (LAA), prior to or during the procedure * Patients requiring a heart transplant, insertion of a ventricular assist device or total artificial heart, and/or ascending aortic aneurysm or dissection repair requiring circulatory arrest * Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score greater than 4 or subject deemed to be high or extreme risk per surgeon assessment * Ejection fraction less than 30% * Chronic Kidney Disease Stage IV or V (estimated glomerular filtration rate (eGFR) \<30 ml/min) * New York Heart Association (NYHA) Class IV heart failure symptoms * Patient has a documented history of substance (drug or alcohol) abuse * Known allergy to device components (Nickel and/or Titanium) * In the opinion of the investigator, the subject is not a suitable candidate for LAA isolation due to risks outweighing potential benefits including, complexity of planned concomitant procedures, or other pre-existing medical conditions * Currently participating in an investigational drug or another device trial or study (excluding registries)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful exclusion of the left atrial appendage (LAA) from the heart | 3 months post procedure | The primary efficacy endpoint is the rate of successful exclusion of the left atrial appendage (LAA) from the heart defined as the absence of residual communication (≤ 3 mm residual contrast communication) between the left atrium (LA) and the left atrial appendage (LAA). For those successfully placed devices, exclusion will be confirmed at 3 months as demonstrated by multi-detector computed tomography (MDCT) scan. |
| Rate of device related adverse events | 30 days post procedure | The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System | At the time of procedure | The secondary efficacy endpoint is defined as the rate of successful placement of the Penditure™ LAA Exclusion System defined as \< 10 mm of residual stump proximal to the clip at the time of the procedure (measured by intraoperative TEE with doppler) without tissue damage requiring intervention. |
| Rate of device related adverse events | At 1 year, 2 year, and 3 years post procedure | The secondary safety endpoint is defined as the composite device-related serious adverse cardiac event rate at 12-months and annually through 36 months. |
Countries
United States
Outcome results
None listed